U.S. patent application number 14/802641 was filed with the patent office on 2015-11-12 for system and methods for using body surface cardiac electrogram information combined with internal information to deliver therapy.
This patent application is currently assigned to CARDIONXT, INC.. The applicant listed for this patent is CardioNXT, Inc.. Invention is credited to Jerome Ranjeev EDWARDS, Paul KESSMAN, Bao NGUYEN.
Application Number | 20150320515 14/802641 |
Document ID | / |
Family ID | 54145307 |
Filed Date | 2015-11-12 |
United States Patent
Application |
20150320515 |
Kind Code |
A1 |
EDWARDS; Jerome Ranjeev ; et
al. |
November 12, 2015 |
SYSTEM AND METHODS FOR USING BODY SURFACE CARDIAC ELECTROGRAM
INFORMATION COMBINED WITH INTERNAL INFORMATION TO DELIVER
THERAPY
Abstract
A system and method for co-registering body surface cardiac
electrogram information to internal information is described. One
embodiment comprises a rigid plate configured to be placed on a
patient that includes imaging fiducials arranged in a unique
orientation with respect to each other; a position sensor
configured to provide position information of the rigid plate;
multiple body surface electrodes coupled to the rigid plate for
measuring cardiac electrical activity of the patient; and a control
unit configured to receive an image scan of the patient, receive
the cardiac electrical activity information from the body surface
electrodes, receive position information of the rigid plate, and
transform the cardiac electrical activity information from its
coordinate system into the coordinate system of the position
information of the rigid plate.
Inventors: |
EDWARDS; Jerome Ranjeev;
(Erie, CO) ; KESSMAN; Paul; (Lakewood, CO)
; NGUYEN; Bao; (Westminster, CO) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
CardioNXT, Inc. |
Westminster |
CO |
US |
|
|
Assignee: |
CARDIONXT, INC.
Westminster
CO
|
Family ID: |
54145307 |
Appl. No.: |
14/802641 |
Filed: |
July 17, 2015 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
PCT/US15/21435 |
Mar 19, 2015 |
|
|
|
14802641 |
|
|
|
|
61955673 |
Mar 19, 2014 |
|
|
|
Current U.S.
Class: |
600/389 ;
600/407; 600/424; 606/34 |
Current CPC
Class: |
A61B 2034/301 20160201;
A61B 2090/3954 20160201; A61B 5/066 20130101; A61B 6/503 20130101;
A61B 8/4254 20130101; A61B 2034/2051 20160201; A61B 5/0037
20130101; A61B 5/0468 20130101; A61N 1/37211 20130101; A61B 5/6852
20130101; A61B 2576/023 20130101; A61B 2090/3983 20160201; A61B
5/6869 20130101; A61B 18/00 20130101; A61B 5/743 20130101; A61B
34/20 20160201; A61B 5/684 20130101; A61B 8/4263 20130101; A61B
2034/107 20160201; A61B 5/6805 20130101; A61B 5/065 20130101; A61B
5/062 20130101; A61B 8/12 20130101; A61B 2090/363 20160201; A61B
6/5288 20130101; A61N 1/37264 20130101; A61B 90/00 20160201; A61B
2090/3782 20160201; A61B 5/04085 20130101; A61B 2090/3966 20160201;
A61B 5/0044 20130101; A61B 5/7289 20130101; A61B 5/064 20130101;
A61B 5/055 20130101; A61B 8/5261 20130101 |
International
Class: |
A61B 19/00 20060101
A61B019/00; A61B 5/06 20060101 A61B005/06; A61B 18/00 20060101
A61B018/00; A61B 5/0408 20060101 A61B005/0408 |
Claims
1. A system, comprising: a rigid plate configured to be placed on a
body of a patient; a position sensor configured to provide position
information of the rigid plate in a first coordinate system; a
plurality of body surface electrodes coupled to the rigid plate,
each body surface electrode configured to be placed on a thorax of
the patient and further configured to measure cardiac electrical
activity of the patient to generate cardiac electrical activity
information; and a control unit configured to (1) receive an image
scan of the patient, the image scan including a representation of
the rigid plate and a representation of the plurality of body
surface electrodes, (2) receive the cardiac electrical activity
information in a second coordinate system, (3) receive the position
information of the rigid plate in the first coordinate system, and
(4) transform the cardiac electrical activity information into the
first coordinate system.
2. The system of claim 1, further comprising: a monitor configured
to display image data, the control unit further configured to
output the image scan and the cardiac electrical activity
information in the first coordinate system in image form to the
monitor for display.
3. The system of claim 1, wherein the position sensor is a first
position sensor and further comprising: a movable internal
instrument having a second position sensor, the movable internal
instrument configured to deliver therapy to the patient to create
non-conductive scar tissue.
4. The system of claim 1, wherein the position sensor is a first
position sensor, the system further comprising: an internal
reference instrument configured to be placed internally in the
patient; and a second position sensor coupled to the internal
reference instrument, the second position sensor configured to
provide position information of the internal reference instrument
in a third coordinate system, the control unit further configured
to receive the position information of the internal reference
instrument in the third coordinate system and transform the cardiac
electrical activity information from the second coordinate system
into the third coordinate system.
5. The system of claim 4, further comprising: a monitor configured
to display image data, the control unit further configured to
output the image scan, the cardiac electrical activity information,
and the position information of the internal reference instrument
in the third coordinate system in image form to the monitor for
display.
6. The system of claim 4, wherein the cardiac electrical activity
information is first cardiac electrical activity information and
further comprising: a second internal instrument having a third
position sensor, the second internal instrument configured to
measure cardiac electrical activity of the patient to generate
second cardiac electrical activity information, the control unit
further configured to transform the second cardiac electrical
activity information into the third coordinate system.
7. The system of claim 4, further comprising: a movable internal
instrument having a third position sensor, the movable internal
instrument configured to deliver therapy to the patient to create
non-conductive scar tissue.
8. The system of claim 6, further comprising: a monitor configured
to display image data; and the control unit further configured to
output the image scan and the second cardiac electrical activity
information and first cardiac electrical activity information in
image form to the monitor for display.
9. The system of claim 1, wherein each body surface electrode from
the plurality of body surface electrodes is a fiducial coupled to
the rigid plate.
10. The system of claim 1, wherein the position sensor is coupled
to the rigid plate and is configured to be repeatably decoupled
from the rigid plate and recoupled to the rigid plate.
11. The system of claim 1, wherein the rigid plate is further
configured to be repeatably decoupled from the plurality of body
surface electrodes and recoupled to the plurality of body surface
electrodes.
12. The system of claim 1, wherein the rigid plate includes an
adhesive surface configured to adhere to the body of the
patient.
13. The system of claim 1, wherein the plurality of body surface
electrodes are included in an electrocardiogram vest.
14. The system of claim 1, wherein the plurality of body surface
electrodes and the rigid plate are included in an electrocardiogram
vest.
15. A system, comprising: a rigid plate configured to be placed on
a body of a patient; a first position sensor coupled to the rigid
plate and configured to provide position information of the rigid
plate in a first coordinate system; a movable instrument configured
to be placed inside the body of the patient, the movable instrument
including a second position sensor configured to provide position
information of the movable instrument in the first coordinate
system; a plurality of body surface electrodes coupled to the rigid
plate, each body surface electrode from the plurality of body
surface electrodes configured to be placed on a thorax of the
patient and further configured to measure cardiac electrical
activity of the patient to generate cardiac electrical activity
information in a second coordinate system; and a control unit
configured to (1) receive the position information of the plate in
the first coordinate system, (2) receive the position information
of the movable instrument in the first coordinate system, (3)
receive the cardiac electrical activity information from the
plurality of body surface electrodes in the second coordinate
system, and (4) transform the cardiac electrical activity
information from the second coordinate system into the first
coordinate system.
16. The system of claim 15, further comprising: a monitor
configured to display image data, the control unit further
configured to output an image scan of the patient and the cardiac
electrical activity information in the first coordinate system in
image form to the monitor for display.
17. The system of claim 15, wherein the movable instrument is
configured to deliver therapy to the patient to create
non-conductive scar tissue.
18. The system of claim 15, wherein the rigid plate is coupled to a
plurality of imaging fiducials, each imaging fiducial from the
plurality of imaging fiducials being distinct from each remaining
imaging fiducial from the plurality of imaging fiducials.
19. The system of claim 15, wherein the first position sensor is
configured to be repeatably decoupled from the rigid plate and
recoupled to the rigid plate.
20. The system of claim 15, wherein the rigid plate is further
configured to be repeatably decoupled from the plurality of body
surface electrodes and recoupled to the plurality of body surface
electrodes.
21. The system of claim 15, wherein the control unit is further
configured to receive an image scan of the patient, the image scan
including at least one of a representation of the rigid plate or a
representation of the plurality of body surface electrodes.
22. A system, comprising: a rigid plate configured to be placed on
a body of a patient, the rigid plate coupled to a first position
sensor configured to provide position information of the rigid
plate in a first coordinate system; an ultrasound imaging
instrument configured to be placed inside the body of the patient,
the ultrasound instrument coupled to a second position sensor
configured to provide position information of the ultrasound
instrument in the first coordinate system; a plurality of body
surface electrodes coupled to the rigid plate, each body surface
electrode configured to be placed on a thorax of the patient and
further configured to measure cardiac electrical activity of the
patient to generate cardiac electrical activity information in a
second coordinate system; and a control unit configured to (1)
receive the position information of the plate in the first
coordinate system, (2) receive the position information of the
ultrasound instrument in the first coordinate system, (3) receive
the cardiac electrical activity information from the plurality of
body surface electrodes in the second coordinate system, and (4)
transform the cardiac electrical activity information from the
second coordinate system into the first coordinate system.
23. The system of claim 22, further comprising: a monitor
configured to display image data, the control unit further
configured to output the position information of the ultrasound
instrument and the cardiac electrical activity information in image
form to the monitory for display.
24. The system of claim 22, wherein the rigid plate is coupled to a
plurality of imaging fiducials, each imaging fiducial from the
plurality of imaging fiducials being distinct from each remaining
imaging fiducial from the plurality of imaging fiducials.
25. The system of claim 22, wherein the first position sensor is
configured to be repeatably decoupled from the rigid plate and
recoupled to the rigid plate.
26. The system of claim 22, wherein the rigid plate is further
configured to be repeatably decoupled from the plurality of body
surface electrodes and recoupled to the plurality of body surface
electrodes.
27. The system of claim 22, wherein the control unit is further
configured to receive an image scan of the patient, the image scan
including at least one of a representation of the rigid plate or a
representation of the plurality of body surface electrodes.
Description
PRIORITY
[0001] This application is a continuation of International
Application No. PCT/US2015/021435, filed Mar. 19, 2015, which
claims priority to U.S. Provisional Patent Application No.
61/955,673, entitled "System and Methods for Integrating Cardiac
Electrical Maps and Intraprocedural Information," filed on Mar. 19,
2014, each of which is incorporated herein by reference in its
entirety.
FIELD OF THE INVENTION
[0002] The invention generally relates to systems and methods that
aid physicians in performing surgical procedures on patients. More
specifically, the invention relates to systems and methods for
non-invasively mapping the electrical activity of the heart and
identifying sources of arrhythmia using electrodes on the patient's
external body surface, projecting that information onto a computer
imaged three-dimensional or four-dimensional model of the heart,
and co-registering the model based on cardiac activity information
with a position localization system which can be used to accurately
navigate instruments during a procedure with respect to the sources
of arrhythmia for treatment of the patient, and further augmenting
the cardiac activity information with real-time intracardiac
recordings from instruments navigated during the surgical
procedure.
BACKGROUND OF THE INVENTION
[0003] There exist very complex cardiac arrhythmias such as Atrial
Fibrillation that are extremely hard to deconstruct to a source
with conventional intracardiac catheters and traditional
twelve-lead electrocardiogram readings. There are high resolution
cardiac electrogram processing techniques that utilize large
numbers of sampling electrodes spread all over a patient's thorax
along with imaging techniques such as computerized tomography or
magnetic resonance imaging to create models of the heart and
project electrical activity at the body surface onto these imaging
models. Ultimately, to make use of this high resolution body
surface cardiac electrogram information for treating patients, the
information must be presented in a manner in which the surgeon can
process that information during a surgery, identify sources of the
arrhythmia, translate that arrhythmia source information to
anatomic information that they are able to manipulate and then
deliver therapy to that source to treat the patient. Further, the
electrical activity of the heart is constantly changing and
measurements acquired from outside the body must be augmented with
measurements acquired from inside the body to best highlight
potential anatomic source regions of the arrhythmia. This must all
be performed in a stable and consistent way, over heart beat and
respiration cycles, so that the surgeon can trust the information
before they deliver therapy to a particular region of the heart.
Serious complications, such as sudden cardiac arrest, stroke,
atrio-esophageal fistula and perforation can occur if therapy is
delivered internally inaccurate based on the body surface cardiac
electrical information.
[0004] Therefore, a practical need exists to have an accurate way
of delivering body surface cardiac electrical information to a
surgeon during a procedure in which they are manipulating
instruments inside the body to diagnose the source of an arrhythmia
and deliver therapy to that source.
SUMMARY OF THE INVENTION
[0005] Embodiments of the invention are summarized below. These and
other embodiments are described in the Detailed Description. It is
to be understood, however, that there is no intention to limit the
invention to the forms described herein. One skilled in the art can
recognize that there are numerous modifications, equivalents, and
alternative constructions that fall within the spirit and scope of
the invention as expressed in the claims.
[0006] In an embodiment, a rigid plate is configured to be placed
on a patient. The rigid plate includes multiple unique imaging
fiducials. A position sensor is configured to provide position
information of the rigid plate. The rigid plate can be coupled to
multiple body surface electrodes that can be placed on the thorax
of the patient. The body surface electrodes can measure cardiac
electrical activity of the patient. A control unit can receive an
image scan of the patient as well as the cardiac electrical
activity information from the body surface electrodes and position
information of the rigid plate. The control unit can transform the
cardiac electrical activity from the body surface electrodes into
the coordinate system of the rigid plate.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] FIG. 1 illustrates an electrical cardiac activity mapping
system and a cardiac instrument position mapping system, according
to an embodiment.
[0008] FIG. 2 illustrates an example of a computer screen output of
an electrical cardiac activity mapping system and cardiac
instrument position mapping system, according to an embodiment.
[0009] FIG. 3 illustrates an example of a computer screen output of
an electrical cardiac activity mapping system output projected onto
a heart model, according to an embodiment.
[0010] FIG. 4 illustrates an example of a use of 12-Lead EKG to map
electrical activity of the heart from the body surface, according
to an embodiment.
DETAILED DESCRIPTION
[0011] In some embodiments, physicians can utilize multiple
independent data components, each data component providing
diagnostic clinical data about a patient. For example, a first data
component can include an electrocardiogram (EKG) map that can
identify an atrial tachycardia. A second data component can include
an instrument position map that identifies the positions of
instruments inside the heart based on a position sensing system
that can aid the physician in manipulating instruments during an
electrophysiology study. The electrocardiogram map can help
localize the region within the atria identified as the source of
ectopic activity driving a cardiac arrythmia. Catheters can be
navigated, using the instrument position map, to that region of the
heart. Further information can be gathered from that region of the
atrium, such as, for example, local activation and voltage, to
identify the specific ectopic pathologic source to treat.
[0012] As shown in FIG. 1, multiple electrodes 105 can be placed on
the body surface of a patient (i.e., body surface electrodes). In
some embodiments, the multiple electrodes 105 can be included in an
EKG electrode vest 115 that can be worn by the patient, as seen in
FIG. 1. In other embodiments, the multiple electrodes 105 can be
individually placed on the surface of the patient's body. In yet
other embodiments, the multiple electrodes 105 can be included in
any other suitable system that allows the medical professional to
place an array of electrodes 105 on the patient, such as, for
example, a blanket that can be placed over the patient, without
requiring the patient to wear it like a garment.
[0013] Referring again to FIG. 1, the EKG electrode vest 115 can be
any suitable, non- conductive material that is radiotranslucent,
such as, for example, cotton, polyester, or rayon. Radiotranslucent
materials do not appear in the final image taken by medical imaging
equipment, such as, for example, magnetic resonance imaging (MRI),
computed tomography (CT) scans, X-Rays, and so forth.
[0014] The multiple electrodes 105 within the electrode vest 115
can be made from any suitable conductive material, such as, for
example, silver-chloride, platinum, copper, or gold. The electrode
array can include any number of electrodes 105. As shown in FIG. 1,
the electrodes 105 can be disposed in a pattern such that each
electrode 105 is substantially the same distance from each
surrounding electrode 105. In other embodiments, the electrodes 105
can be disposed in any other pattern and/or can be disposed such
that the electrodes 105 are different distances from each
surrounding electrode 105.
[0015] Also on the EKG electrode vest 115, as shown in FIG. 1, can
be a rigid plate 110. The rigid plate 110 can be any suitable,
radiotranslucent, rigid material including, for example, plastic.
In some embodiments, the rigid plate 110 can be any non-ferrous
material such that the rigid plate 110 can be used in MRI
environments. In some embodiments, the rigid plate 110 can include
an adhesive on the surface of the rigid plate 110 for securing the
rigid plate 110 to the patient's body surface.
[0016] While shown in FIG. 1 as part of the electrode vest 115, in
some embodiments, the multiple electrodes 105 and/or rigid plate
110 can be placed on the patient's body individually, without being
part of a garment. In other embodiments, the rigid plate 110 can be
included in any other suitable system that can allow a medical
professional to place the rigid plate and/or multiple electrodes
105 on the patient without being part of a garment, such as, for
example, a blanket.
[0017] The rigid plate 110 can include radiopaque fiducials (i.e.,
markers) 120, 125, 130, 135 such that the fiducials 120, 125, 130,
135 do appear in the final image taken by medical imaging
equipment. Radiopaque fiducials 120, 125, 130, 135 can be any
suitable material such that the fiducial 120, 125, 130, 135 will
enhance in, for example, MRI, CT, or X-Ray imagery, such as, for
example, steel or copper. In some embodiments, the fiducial 120,
125, 130, 135 can be soaked in a contrast medium such as, for
example, gadolinium, such that it will enhance in MRI imaging. The
rigid plate 110 and associated fiducials 120, 125, 130, 135 can be
designed with a correct consistency of radiopacity to enhance in
cone-beam-CT or other forms of intraprocedural X-Ray imaging. The
radiopaque fiducials 120, 125, 130, 135 can be any suitable shape
including, for example, circular, donut, triangular, square, and/or
rectangular. The fiducials 120, 125, 130, 135 are also sometimes
called imaging fiducials because they appear in imaging output.
[0018] In some embodiments, one or more fiducials 120, 125, 130,
135 can be electrodes and wiring used to collect body surface
electrogram information (i.e., cardiac electrical activity
information). In some embodiments, one or more fiducials 120, 125,
130, 135 can be position sensors to a position tracking system.
[0019] In some embodiments, the rigid plate 110 can be radiopaque
and the fiducials 120, 125, 130, 135 can be a cutout in the rigid
plate such that the rigid plate will appear in the final image
taken by a medical imaging system. Such a configuration can allow
the unique shape of the fiducial 120, 125, 130, 135 to appear in
the image as contrasted with the rigid plate 110. Similarly stated,
rather than a radiopaque fiducial 120, 125, 130, 135, the fiducial
120, 125, 130, 135 can be a void in the radiopaque rigid plate 110,
which can still be visible in the final image from the medical
imaging system (i.e., an imaging fiducial).
[0020] In some embodiments, the rigid plate 110 can include
cut-outs for standard medical diagnostics placed on patients such
as, for example, 12-Lead EKG pads.
[0021] Included on the rigid plate 110 can be multiple
electromagnetic position sensors 140, 145. The multiple
electromagnetic sensors 140, 145 can be any suitable
electromagnetic sensor such as, for example, a copper coil winding
or a gold coil winding. The electromagnetic sensors 140, 145 can be
disposed on the rigid plate 110 orthogonally to one another, as
shown in FIG. 1. Each electromagnetic sensor 140, 145 can include a
lead 150 that can allow the sensor signal to be captured by a
position sensing system coupled to the lead. In some embodiments,
the rigid plate 110 can include a housing to enable the
electromagnetic position sensors 140, 145 to be removably coupled
(e.g., clipped in and out) such that the position sensors 140, 145
can be removed and added with repeatability and
reproducibility.
[0022] The fiducials 120, 125, 130, 135 and electromagnetic sensors
140, 145 on the rigid plate 110 can be disposed such that each is a
known distance between the other components. For example, as shown
in FIG. 1, the circular fiducial 130 is a known distance from the
electromagnetic sensor 140.
[0023] The multiple electrodes 105 within the EKG electrode vest
115 can be electrically coupled to the rigid plate 110. The rigid
plate 110 can be disposed within the vest 115 (e.g., sewn in or
embedded) such that it is located over a particular area of the
patient, such as, for example, the patient's sternum, during the
medical procedure, as shown in FIG. 1. In other embodiments, the
rigid plate 110 can be located over any other location of the
patient's body.
[0024] In some embodiments, the rigid plate 110 can be multiple
rigid plates 110. The multiple rigid plates 110 can be placed on
multiple places on the patient's body. In some embodiments, each
rigid plate 110 can be a unique shape and/or include a unique
pattern. In embodiments using multiple rigid plates, each rigid
plate 110 can include position sensors, such as, for example,
electromagnetic sensors 140, 145. In other embodiments, only some
rigid plates 110 include position sensors.
[0025] In some embodiments, the rigid plate 110 can include unique
markings or the uniquely shaped plate, or the uniquely shaped
fiducials 120, 125, 130, 135 can be used in realigning the
electrodes 105 used to measure electrogram signals from the body
surface after they have been removed. For example, each rigid plate
110 can include markings that enable a medical professional to
precisely realign the rigid plate 110 on the patient's body (e.g.,
the sternum) if the rigid plate 110 is removed from the patient's
body. For example, the markings in the rigid plate 110 can be a
uniquely shaped cutout, which can allow the medical professional to
mark that shape on the patient or the EKG electrode vest 115 before
removing the rigid plate 110 from the patient. At a later time, the
marking can be aligned with the cutout such that the rigid plate
110 is precisely relocated on the patient. Each rigid plate 110 can
include a mechanism for removal and reattachment to the patient's
body, such as, for example, a detachable base plate or a sticker
that remains affixed to the patient while the rigid plate 110 is
removed. Such a removal and reattachment mechanism can aid in
re-aligning the rigid plate 110 on the patient at a later time.
[0026] Using the multiple electrodes 105, surface electrograms
(EKGs) can be measured. The patient can also be imaged with the
multiple electrodes 105 using, for example, Computed Tomography
(CT). Using that image data, a model of the heart can be
constructed. The cardiac electrogram data that is being measured
using the multiple electrodes can be projected onto that model of
the heart, as disclosed by U.S. Pat. No. 7,983,743 to Rudy, et al,
which is incorporated by reference herein in its entirety.
Similarly, 12-Lead EKG information can be projected onto a model of
the heart as seen in FIG. 4 to gain a high-level understanding of
the patient heart function.
[0027] In some embodiments including multiple rigid plates 110
and/or fiducials 120, 125, 130, 135 that are uniquely shaped,
specific fiducials 120, 125, 130, 135 can be segmented out of
imagery easily. Specifically shaped fiducials 120, 125, 130, 135
can also aid in correlating the orientation of the fiducials 120,
125, 130, 135 in relation to unique sensors that can be placed on
the body. As seen in FIG. 1, the two electromagnetic position
sensor coils 140, 145 can be positioned orthogonally on the
patient. The vector from the center of the triangle fiducial 135 to
the square fiducial 120 establishes an axis that is parallel to the
orientation of the first electromagnetic position sensor 140 on the
body. The vector from the center of the circle fiducial 130 to the
center of the square fiducial 120 establishes an axis that is
parallel to the orientation of the second electromagnetic position
sensor 145 on the body. Once the fiducials 120, 125, 130, 135 are
identified in the coordinate system of the image data, the
fiducials 120, 125, 130, 135 can enable identification of the
location and orientation of each position sensor 140, 145 on the
body within the image data coordinate system. When the position
sensors 140, 145 are connected to a position sensing system, the
volume and coordinate system of the image data can be determined in
the coordinate system of the room or position sensing system, also
defined as a method of segmentation, correlation, and
registration.
[0028] In some embodiments, the rigid plate 110 can be electrically
coupled to one or more electrodes 105. In such embodiments, the
electrodes 105 can drive current through the patient's body to
serve as a the basis for a position locating system of instruments
within the body as disclosed in U.S. Pat. No. 5,983,126 to
Wittkampf, et al., which is incorporated herein by reference in its
entirety.
[0029] In use, the patient can be image scanned (e.g., CT scanned)
with the multiple electrodes 105 and the rigid plates 110 applied
to the patient. The scan can be displayed on a computer monitor
155, such as, for example, as shown in FIG. 1. As shown in the CT
scan 155 in FIG. 1, the radiopaque fiducials 120, 125, 130, 135 can
appear in the CT scan 155. The CT scan 155 in FIG. 1 is a
two-dimensional image as it is a cross section. In some
embodiments, the CT scan 155 can be a stack of two dimensional
images (e.g., a CT slice stack, acquired as the CT scanner moves
axially from head to toe along the axis of the patient's spine) to
create a three-dimensional image such that the fiducials 120, 125,
130, 135 can appear in the image fully as, for example, a circle or
rectangle rather the small marks in the CT scan shown in FIG. 1. In
some embodiments, other types of imaging equipment can be used,
such as, for example, X-Ray or MRI.
[0030] Software instructions running on a computer that is a part
of a position location system can be programmed to receive that
image scan data and automatically identify and segment out the
unique fiducials 120, 125, 130, 135 associated with respect to the
rigid plate 110. Software instructions can be programmed to search
for the unique shapes of the fiducials 120, 125, 130, 135 and their
geometric orientation in order to determine the location and
correlation of position sensors 140, 145 associated with the rigid
plate 110 in the coordinate system of the image data (i.e., sensor
#1 in position #1 in an image coordinate system and sensor #2 in
position #2 in the image coordinate system).
[0031] A position tracking system, such as the one disclosed in
U.S. patent application Ser. No. 13/747,266 to Edwards, et al., can
be applied to the patient. As shown in FIG. 1, an internal
reference instrument 160, such as a coronary sinus catheter
including a position sensor can be inserted into a stable position
within the human heart, such as, for example, the coronary sinus.
The electromagnetic sensors 140, 145 coupled to the rigid plate 110
can be connected to the position tracking system. The position
tracking system can identify the position of internal sensors and
external body surface sensors. The position tracking system can
send the signals from the internal sensors and external body
surface sensors (i.e., EKG signals and electromagnetic sensor
signals 140, 145) to a computer having software instructions for
evaluating the signals to identify coordinates for each of the
sensors. The coordinates of the sensors within the image data can
be used to calculate a transformation of any image data and
associated cardiac electrogram data (i.e., body surface electrogram
image data) into the coordinate system of the rigid plate 110 and
its associated position sensors 140, 145. A transformation matrix
can be constructed to apply to any body surface electrogram image
data to transform it into the coordinate system of the rigid plate
110. The coordinates of the rigid plate 110 related to its position
sensors 140, 145 and the coordinates of the internal reference
instrument 160 and its associated position sensors in the
coordinate system of the position tracking system can be measured.
A transformation matrix can be constructed to apply to any
information associated with the rigid plate 110 to transform it
into the coordinate system of the internal reference instrument
160. Using the transformation matrices, all body surface
electrogram data can be transformed into the coordinate system of
the internal reference instrument 160 (e.g., by multiplying the
body surface electrogram data by the concatenated transformation
matrices). This transformation process can be repeated
continuously.
[0032] During use, the patient's heart can shift internally with
respect to the external body surface rigid plate 110. In such
instances, the second transformation matrix can be updated and
applied to electrogram data such that it will be projected onto
images of the heart accurately. Accuracy can be maintained during
minor and major internal changes, such as, for example, if the
patient's left lung hyper-inflates during a procedure due to a
complication associated with tracheal intubation. As another
example, accuracy can be maintained if, for example, the patient's
heart shifts with respect to the external electrodes or
fiducials.
[0033] Body surface electrogram information can be automatically
registered to a consistent position tracking system and its
associated internal reference instrument. The position of other
instruments tracked by the tracking system can be displayed in the
same consistent tracking system, such as, for example, as depicted
in FIG. 2.
[0034] As shown in FIG. 2, a single interface can show the medical
professional the positions of electrogram information acquired from
the patient's body surface, therapy points 210, intraprocedural
annotations, and/or the medical instruments 215 both on an
intraprocedurally constructed model of a heart 220 as well as on an
image of the patient's heart 230 collected from body surface
electrodes. Stated another way, the information obtained from the
multiple electrodes 105, rigid plate 110, fiducials 102, 125, 130,
135, position sensors 140, 145, and internal reference instrument
160 can be overlaid on an image of the patient's heart. The image
of the patient's heart can be constructed from, for example, the
imaging data from, for example, a CT scan 155, MRI, or X-Ray. The
transformation process described above can be used to transform all
the data into a single coordinate system for display to the user in
a unified manner, as shown in FIG. 2.
[0035] During the course of the procedure, medical instruments such
as, for example, a roving ablation catheter, a multi-electrode
loop, a multi-electrode star, and/or a multi-electrode basket can
be tracked by the position tracking system. The medical instrument
can be for example, internal reference instrument 160 of FIG. 1. As
shown in FIG. 3, information can be measured from points within the
heart such as voltage 310, temperature, impedance, dominant
frequency, conduction velocity 320, force, and hemodynamic
pressure.
[0036] FIGS. 3a and 3b are models of a heart showing conduction
velocity 320 and potential rotor locations 330. The conduction
velocity 320 is information that can be obtained by, for example,
internal reference instrument 160 (FIG. 1). This information can be
sent to a computer for analysis. Similarly, potential rotor
location 330 is information that can be obtained by, for example,
internal reference instrument 160 (FIG. 1). Techniques for
collecting and analyzing rotor information, such as the techniques
disclosed in U.S. patent application Ser. No. 14/466,588 to
Edwards, et al., hereby incorporated by reference in its entirety,
can be used. The information obtained from internal reference
instrument 160 can be displayed to the user as an overlay on the
model of the heart constructed by the computer, as shown in FIGS.
3a and 3b.
[0037] FIG. 3c is similarly a model of a heart showing voltage
information. The voltage information can be collected by, for
example, internal reference instrument 160 (FIG. 1). The
information can similarly be overlaid on the model of the heart
constructed by the computer, as shown in FIG. 3c.
[0038] The medical instrument, such as internal reference
instrument 160 (FIG. 1) can be configured to measure that
information and send it to a processor for analysis. This
information can be merged on the model of the heart in a
co-registered manner with the body-surface electrogram data 225
using the position data from the internal instruments with respect
to the internal reference instrument 160 (FIG. 1), such as shown in
FIG. 2. For example, the multiple electrodes 105 (FIG. 1) can
provide body-surface electrogram data 225 (FIG. 2). Also shown in
FIG. 2 is the model of the heart 220 and image of the heart 225,
each from image data obtained from, for example, a CT scan, MRI, or
X-Ray, as described elsewhere herein. Further shown in FIG. 2 is
position information of an internal reference instrument 215,
obtained from a position sensor as described elsewhere herein. All
of this information can be obtained from different sources and
transformed into a single coordinate system for display to the user
using the transformation process described above.
[0039] The combination of co-registered external and internal based
cardiac information can be used in planning therapeutic procedures
and augmenting those plans during surgery. Specifically, external
body surface electrogram information can be used to identify,
annotate, and plan the vicinity of a target location for therapy
delivery on a heart image model. During the procedure, various
information data such as voltage transitions can be obtained from
an internal instrument tracked with respect to the internal
reference instrument and co-registered to the external body-surface
electrogram information to augment initial treatment plans.
[0040] Therapy can be provided by an internal instrument, for
example, a roving ablation catheter. In some embodiments, there are
multiple internal instruments. For example, the system can include
body surface electrodes to collect cardiac electrical activity of
the patient from the body surface of the patient as described
above. As also described above, an internal reference instrument
can be used to collect cardiac electrical activity of the patient
from, for example, the coronary sinus. In this way, both internal
measurements and external measurements can be collected and used to
provide images of the heart that map or show the location of
instruments in relation to each other and their location within the
patient's body. Further, there can be an internal roving
instrument, such as a roving ablation catheter, that can be
introduced into the patient's body. The internal roving instrument
can include a position sensor to provide the position information
to the processor. The processor can convert the position
information of the internal roving instrument into any of the
coordinate systems already in use such that the location of the
internal roving instrument can also be presented with the
information of the other instrument information on the model of the
heart on the display being used by the surgeon. The surgeon can
utilize the information to provide therapy to the patient. For
example, a roving ablation catheter can be used to ablate tissue in
the patient's heart that may be causing atrial fibrillation. In
some embodiments, the internal roving instrument can be configured
to provide therapy that creates non-conductive scar tissue.
[0041] In some embodiments, for example, body surface electrogram
information on a heart model may be used to identify the optimal
site to place a pacemaker or defibrillator lead or an entirely
miniaturized pacemaker or defibrillator to ensure optimal current
flow from the stimulation source through diseased or scarred tissue
to stimulate the heart in a manner that resonates with sinus rhythm
as opposed to introducing current flow patterns that may cause
another unwanted arrhythmia. During the surgery, additional
measurements may be taken from a tracked internal instrument to
further understand patient characteristics internally, such as
voltage transitions indicating scar tissue, and that information
can be merged with the original model of the heart and the
associated body surface electrogram information. This combined
information can be used to tune the output settings of a pacemaker
or defibrillator based on external and internal information of the
patient. Similar methods of treatment delivery can be constructed
for biological drug delivery such as nano-particles, stem-cells,
gene therapy.
[0042] Once the model of the heart is constructed, an ultrasound
probe with its own position sensor capable of being tracked by the
position tracking system can be used to create a second model of
the heart in the same co-registered coordinate system originating
from the body surface electrogram data. The first model of the
heart and all associated information can be linearly or
non-linearly deformed to mold to the secondary model of the heart.
A sound measuring device or set of devices with integrated position
sensors can be affixed to the patient's body surface. The speed of
sound measurements reaching the external sound measuring devices
from a tracked internal ultrasound transducer can be used to
augment initial body surface electrogram calculations and
associated projections onto a heart model.
[0043] Once the data is integrated and co-registered into the
coordinate system of the internal reference instrument and its
position tracking system, a tracked catheter with one or more
magnetic elements may be positioned with the use of high field
magnets in order to position that catheter to a target location
defined by the co-registered information beginning with the body
surface electrogram information.
[0044] Once the data is integrated and co-registered into the
coordinate system of the internal reference instrument and its
position tracking system, a tracked catheter, shrouded by a robotic
sheath, may be positioned with the use of robotic sheath
manipulator in order to position that catheter to a target location
defined by the co-registered information beginning with the body
surface electrogram information.
[0045] Once the data is integrated and co-registered into the
coordinate system of the internal reference and its position
tracking system, an external radiation beam source may be
positioned with the use of a robotic manipulator in order to
position the beam to a target location defined by the co-registered
information beginning with the body surface electrogram
information.
[0046] It is intended that the systems and methods described herein
can be performed by software (stored in memory and/or executed on
hardware), hardware, or a combination thereof. Hardware modules may
include, for example, a general-purpose processor, a field
programmable gate array (FPGA), and/or an application specific
integrated circuit (ASIC). Software modules (executed on hardware)
can be expressed in a variety of software languages (e.g., computer
code), including Unix utilities, C, C++, Java.TM., Ruby, SQL,
SAS.RTM., the R programming language/software environment, Visual
Basic.TM., and other object-oriented, procedural, or other
programming language and development tools. Examples of computer
code include, but are not limited to, micro-code or
micro-instructions, machine instructions, such as produced by a
compiler, code used to produce a web service, and files containing
higher-level instructions that are executed by a computer using an
interpreter. Additional examples of computer code include, but are
not limited to, control signals, encrypted code, and compressed
code. Each of the devices described herein can include one or more
processors as described above.
[0047] Some embodiments described herein relate to devices with a
non-transitory computer-readable medium (also can be referred to as
a non-transitory processor-readable medium or memory) having
instructions or computer code thereon for performing various
computer-implemented operations. The computer-readable medium (or
processor-readable medium) is non-transitory in the sense that it
does not include transitory propagating signals per se (e.g., a
propagating electromagnetic wave carrying information on a
transmission medium such as space or a cable). The media and
computer code (also can be referred to as code) may be those
designed and constructed for the specific purpose or purposes.
Examples of non-transitory computer-readable media include, but are
not limited to: magnetic storage media such as hard disks, floppy
disks, and magnetic tape; optical storage media such as Compact
Disc/Digital Video Discs (CD/DVDs), Compact Disc-Read Only Memories
(CD-ROMs), and holographic devices; magneto-optical storage media
such as optical disks; carrier wave signal processing modules; and
hardware devices that are specially configured to store and execute
program code, such as Application-Specific Integrated Circuits
(ASICs), Programmable Logic Devices (PLDs), Read-Only Memory (ROM)
and Random-Access Memory (RAM) devices. Other embodiments described
herein relate to a computer program product, which can include, for
example, the instructions and/or computer code discussed
herein.
[0048] While various embodiments have been described above, it
should be understood that they have been presented by way of
example only, and not limitation. Where methods and/or schematics
described above indicate certain events and/or flow patterns
occurring in certain order, the ordering of certain events and/or
flow patterns may be modified. While the embodiments have been
particularly shown and described, it will be understood that
various changes in form and details may be made.
[0049] Although various embodiments have been described as having
particular features and/or combinations of components, other
embodiments are possible having a combination of any features
and/or components from any of embodiments as discussed above.
* * * * *